Quality Engineer I
MedtronicAbout the role
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
A Day in the Life
In this meaningful role as a Quality Engineer I supporting Cardiac Ablation Solutions (CAS), you will play a vital part in ensuring product quality, safety, and reliability through post‑market activities. You will perform complaint investigations, partner closely with engineering teams to identify and escalate risk file signals, and support data‑driven decisions that protect patients and clinicians.
This role supports the development and continuous improvement of procedures, processes, tools, and techniques used for product analysis and returned product evaluation. You will devise and implement inspection and testing methods for returned product, support test method validation efforts, and apply appropriate statistical methodologies to assess product performance and trends.
In addition, this position contributes to building organizational capability by providing training to technicians and strengthening consistent, compliant execution of quality practices—directly supporting patient safety and the CAS product lifecycle.
Job Description
In general, the following responsibilities apply for the Quality Engineer II role. This includes, but is not limited to the following:
• Perform complaint investigations for Cardiac Ablation Solutions products
• Collaborate with the engineering team to escalate risk file signals as appropriate.
• Provide support with the development of procedures, processes, tools, and techniques for performing product analysis.
• Devise and implement methods and procedures for inspection and testing of returned product.
• Support test method validation activities.
• Apply and understand statistical methodologies, as appropriate.
• Provide training to technicians.
Must Have - Minimum Requirements
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
• Bachelor’s degree in Engineering, Science, or a related technical discipline.
Nice to Have
• Medical device industry experience.
• Familiarity with these regulations: FDA 21 CFR Part 820, EU 217/745 (EU MDR).
• Familiarity with these standards: ISO 13485, ISO 14971, IEC 60601.
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• Strong written and verbal communication skills and ability to wor
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